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Ceftibuten dihydrate - Generic Drug Details

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Ceftibuten dihydrate is the generic ingredient in one branded drug marketed by Pernix Therap and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for Generic Name: ceftibuten dihydrate

Tradenames:1
Patents:0
Applicants:1
NDAs:2
Drug Master File Entries: 0
Suppliers / Packaging: see list2
Therapeutic Class:Antibacterials

Pharmacology for Ingredient: ceftibuten dihydrate

Clinical Trials for: ceftibuten dihydrate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pernix Therap
CEDAX
ceftibuten dihydrate
CAPSULE;ORAL050685-002Dec 20, 1995DISCNNo<disabled><disabled>
Pernix Therap
CEDAX
ceftibuten dihydrate
FOR SUSPENSION;ORAL050686-002Dec 20, 1995DISCNNo<disabled><disabled>
Pernix Therap
CEDAX
ceftibuten dihydrate
FOR SUSPENSION;ORAL050686-001Dec 20, 1995DISCNNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: ceftibuten dihydrate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pernix Therap
CEDAX
ceftibuten dihydrate
FOR SUSPENSION;ORAL050686-002Dec 20, 19954,812,561<disabled>
Pernix Therap
CEDAX
ceftibuten dihydrate
FOR SUSPENSION;ORAL050686-002Dec 20, 19955,599,557<disabled>
Pernix Therap
CEDAX
ceftibuten dihydrate
CAPSULE;ORAL050685-002Dec 20, 19954,634,697<disabled>
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